Radioactive tracer aims to spot kidney cancer with sharper eyes
NCT ID NCT06916624
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing a radioactive tracer called 18F-NY104 to see how well it detects kidney cancer and other tumors that carry a protein called CAIX. About 120 people with known or suspected kidney cancer, or other CAIX-positive cancers, will receive an injection of the tracer and then undergo a PET/CT scan. The study also checks whether a low dose of the drug acetazolamide changes where the tracer goes in the body, which might improve image quality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-NY104, a radioactive tracer for PET/CT imaging
- What this could lead to
- If it works, this tracer could offer a more precise way to find kidney cancer and track how well treatment is working, and it might help image other cancers that carry the CAIX protein.
- What could go wrong
- The tracer may not light up tumors clearly enough, or it could accumulate in organs like the stomach and kidneys and obscure the view. The study is small and early, so results may not hold up in larger groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The cohort primarily included patients who were clinically diagnosed with or suspected to have renal cell carcinoma (RCC), those with suspected recurrence or metastasis after treatment of RCC, and patients with CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements; 2. Age 18-75 years; no gender restrictions; 3. Clinically diagnosed/suspected renal cell carcinoma, clinically diagnosed/suspected recurrence and/or metastasis after treatment of renal cell carcinoma, or CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma; 4. At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1); 5. ECOG performance status score of 0-2; 6. Laboratory parameters must meet: 1. Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; PT or APTT ≤1.5×ULN (upper limit of normal); 2. Liver and kidney function: T-Bil ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis is present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN; 3. Other routine tests: Within normal ranges or deemed acceptable by the investigator; 7. Expected survival ≥12 weeks; 8. Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives/agents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study. Exclusion Criteria: 1. Recovery from major trauma (including surgery) within 4 weeks prior to study examination; 2. Patients with systemic or local severe infections or other serious comorbidities; 3. Severe hepatic or renal dysfunction; 4. Refusal to participate in this clinical study; 5. Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution; 6. Childbearing-aged male or female subjects who cannot adopt effective contraception; 7. Women planning pregnancy, currently pregnant, or lactating; 8. Patients unable or unwilling to undergo PET/CT scanning; 9. Other subjects deemed ineligible by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Affiliated Hospital of Qingdao University
RECRUITINGQingdao, Shandong, China
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Other studies related to the condition(s) this trial covers.
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